34: Is ICH Q9 Training a Reset for Risk Management?

Is the new ICH Q9 training just more guidance—or a reset for how risk should be managed?

In this episode, we break down the latest training materials and what they signal for Quality Risk Management (QRM) in practice.

We cover:

• Why this release feels like a shift in expectations—not just an update
• The gap between risk tools and real decision-making
• Challenges applying dense guidance in real-world settings
• What organizations may need to rethink in existing QRM programs

If your team is focused on completing risk assessments rather than improving decisions, this episode will challenge your approach.